Aseptic Manufacturing Specialist - On-Site 1st Shift

Alcami-5; North Charleston (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

Alcami is seeking a Manufacturing Specialist - Aseptic to support cGMP sterile drug product manufacturing and troubleshoot manufacturing events. The role involves preparing, conducting, and evaluating continued process verification activities, and providing ongoing support to commercial and clinical manufacturing.

Collaboration with Formulation Development, Manufacturing, QA and Regulatory, EHS and Engineering is essential to ensure robust production of sterile products.

Qualifications

• Related bachelor's degree preferred with 2+ years related experience in the manufacture of sterile injectable products in a regulated environment.
• Or applicants with high school or equivalent certification with 8+ years related experience in the manufacture of sterile injectable products in a regulated environment.
• Must have at least 1 year of experience in technical writing (deviations, SOPs, batch records, etc.).
• Must have demonstrated leadership and training experience.

Responsibilities

• Perform data analysis, including tracking and trending of manufacturing processes to identify areas of improvement.
• Measure and evaluate unit operation durations to implement optimal scheduling to meet facility and client requirements.
• Author Change Controls to support investigations, process changes and equipment modifications.
• Author investigations and facilitate the closure of investigations on time.
• Review and approve new batch records as well as perform review of executed batch records.
• Provides training to manufacturing staff on operating procedures, batch records and GMP process rationale.
• Provides technical, on the floor support of commercial, clinical, and validated processes.
• Supports clients/stakeholders as a subject matter expert of commercial, clinical, and generic products.
• Evaluates product impact of process excursions outside proven acceptable ranges.

Skills

Leadership

Training

Data analysis

GMP

Education

Bachelor's degree

High school diploma or equivalent with 8+ years experience

Tools

Microsoft Office

Job description

Alcami is seeking a Manufacturing Specialist - Aseptic to support cGMP sterile drug product manufacturing and troubleshoot manufacturing events. The role involves preparing, conducting, and evaluating continued process verification activities, and providing ongoing support to commercial and clinical manufacturing.

Collaboration with Formulation Development, Manufacturing, QA and Regulatory, EHS and Engineering is essential to ensure robust production of sterile products.